Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Basic Information
- Device Name
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Trade Name
- Oncomine Dx Express Test
- PMA Number
- P240040
- Device Class
- FDA Class 3
- Product Code
- PQP
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 2, 2025
- Date Received
- November 12, 2024
- Expedited Review
- N
Advisory Committee Statement
Approval for the Oncomine Dx Express Test. The test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect substitutions, insertions, and deletions in 42 genes from DNA, copy number variants (CNVs) in 10 genes from DNA, and fusions or splice variants in 18 genes from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor samples, using the Genexus Dx Integrated Sequencer. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling (see approval order for Table 1).Additionally, the test is intended to provide tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | FDA class 3 | Unknown |